BEIGENE Shares Rise Nearly 3% on FDA Accelerated Approval for Sotoklara and Strong Q1 Earnings Beat

Stock News05-20

BEIGENE (06160) shares rose nearly 3%. As of writing, the stock was up 2.23% to HKD 178.7, with a turnover of HKD 467 million.

The company announced that BEQALZI™ (sotoklara) received accelerated approval from the U.S. Food and Drug Administration (FDA) on May 13, 2026 (Eastern Time). The drug is approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a BTK inhibitor.

Previously, BEIGENE disclosed its first-quarter 2026 results. Revenue reached USD 1.513 billion, a year-over-year increase of 35%. Product revenue was USD 1.487 billion, up 34% year-over-year. GAAP net profit was USD 227 million, an increase of USD 226 million compared to the same period last year. While sales revenue met expectations, net profit exceeded forecasts, primarily due to effective cost control.

Global sales of zanubrutinib in Q1 2026 were USD 1.095 billion, a year-over-year increase of 38%. U.S. sales contributed USD 761 million, up 35% year-over-year. This growth is attributed to strong demand for zanubrutinib and benefits from net pricing, allowing it to maintain a leading position in new chronic lymphocytic leukemia patients.

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